PLACE LABEL HERE INFORMED CONSENT FOR ARTERIOVENOUS DIALYSIS SHUNTOGRAM (This form is designed to comply with the Georgia Informed Consent Law O.C.G.A. 31-9-6.1) PATIENT NAME: _____________________________________ DATE: ________________________ TIME: ________________________ The diagnosis or clinical history requiring this procedure is: dialysis graft narrowing or blockage.___________________ _________________________________________________________________________________________________ The nature of the procedure is: Arteriovenous Dialysis Shuntogram – 1.) Evaluate the graft by injecting x-ray_____ contrast (dye) into the arm fistula and take x-ray images. 2.) Angioplasty – dilate any narrowing if needed with a balloon or stent, and 3.) Anticoagulation Therapy – infusion of blood thinners or clot busting agent. 4.) Use of mechanical_____ thrombectomy device.________________________________________________________________________________ The purpose of this procedure is: to diagnose and treat narrowing of dialysis graft.______________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ THIS PROCEDURE INVOLVES THE MATERIAL RISK OF INFECTION, ALLERGIC REACTION, SEVERE LOSS OF BLOOD, LOSS OR LOSS OF FUNCTION OF ANY LIMB OR ORGAN, PARALYSIS, PARAPLEGIA OR QUADRIPLEGIA, DISFIGURING SCAR, BRAIN DAMAGE, CARDIAC ARREST OR DEATH. ADDITIONAL RISKS: In addition to the material risks listed above, there may be other potential risks involved in this procedure including, but not limited, to the following: bleeding, infection, dye allergy, or injury to the fistulas which could require surgery to repair.______________________________________________________________________________ __________________________________________________________________________________________________ The likelihood of success of this procedure is: [ x ] good [ ] fair [ ] poor THE PRACTICAL ALTERNATIVES TO THIS PROCEDURE ARE: no intervention or surgical repair._____________________ __________________________________________________________________________________________________ If I choose not to have the above procedure, my prognosis (future medical condition) is: uncertain._________________ __________________________________________________________________________________________________ I understand that during the course of the procedure described above, it may be necessary or appropriate to perform additional procedures which are unforeseen or not known to be needed at the time consent is given. I consent to and authorize the persons described herein to make the decisions concerning such procedures. I also consent to and authorize the performance of such additional procedures as they deem necessary or appropriate. I consent to diagnostic studies, tests, x-ray examinations and any other treatment or courses of treatment relating to the diagnosis or procedures described herein. *2-13005* FORM 2-13005 REV. 03/2006 Page 1 of 2 I consent to the use of IV sedation and/or anesthesia and understand the risks are those associated with the procedure itself as listed above. The options have also been explained to me. I consent to the use of blood and blood products as deemed necessary. The risks of exposure to AIDs, hepatitis or other infectious diseases as well as the need for and available alternatives have been explained to me. I consent that any tissues, specimens, organs or limbs removed from my body in the course of any procedure may be tested or retained for scientific or teaching purposes and then disposed of within the discretion of the physician, facility or other health care provider. I understand that the physician, medical personnel and other assistants will rely on statements about the patient, the patient’s medical history, and other information in determining whether to perform the procedure or the course of treatment for the patient’s condition and in recommending the procedure which has been explained. I understand that the practice of medicine is not an exact science and that NO GUARANTEES OR ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure. BY SIGNING THIS FORM, I ACKNOWLEDGE THAT I HAVE READ OR HAD THIS FORM READ AND/OR EXPLAINED TO ME IN GENERAL TERMS, THAT I FULLY UNDERSTAND ITS CONTENTS, THAT I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND THAT ANY QUESTIONS HAVE BEEN ANSWERED SATISFACTORILY. ALL BLANKS OR STATEMENTS REQUIRING COMPLETION WERE FILLED IN AND ALL STATEMENTS I DO NOT APPROVE OF WERE STRICKEN BEFORE I SIGNED THIS FORM. I ALSO HAVE RECEIVED ADDITIONAL INFORMATION, INCLUDING, BUT NOT LIMITED TO THE MATERIALS LISTED BELOW, RELATED TO THE PROCEDURE DESCRIBED HEREIN. I hereby voluntarily request and consent for Dr.____________________, as my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described or referred to herein. I further consent to the presence of device or supply manufacturer’s representatives in the operating room as may be deemed appropriate by my physician. Additional materials used, if any, during the informed consent process for this procedure include: __________________ __________________________________________________________________________________________________ ___________________________________ Signature of Person Giving Consent ___________________________________ Relationship to patient if not the patient Patient unable to sign because: Responsible Practitioner’s Statement: ____________________________________________________ I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed procedure, with the patient or the patient’s decision-maker, and have provided the patient/decision-maker with an opportunity to ask questions. ___________________________________ Responsible Practitioner FORM 2-13005 REV. 03/2006 ___________________________________ Date/Time Page 2 of 2